Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Qualifications

Job description

Join our Parenteral Product Development Science and Technology - Analytical Development group and contribute to exciting programs transitioning from the development stage to optimization and commercialization. As a member of the team, you will support the development, optimization, and validation of analytical methods by ensuring that they are well documented. You'll gain experience in documentation of product control strategies, analytical methods, and stability studies. This is not a laboratory position.

Responsibilities:

• Support Analytical Leads and Lab Managers by assisting with the creation and review of protocols, reports, specifications, and other technical documents. 
• This may include facilitating communication between different laboratories, reviewing data, drafting sections and data tables, data verification, and other tasks as needed.
• Execute change management processes for document updates.
• Assist in compiling and verifying information for submissions and responding to health authority queries.
• Gain hands-on experience in regulatory compliance and analytical data.

Requirements:

• Bachelor’s Degree in a scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) and 5+ years’ experience or Master’s Degree with 2+ years’ experience.
• Basic understanding of analytical methods, test method validation, and Good Documentation Practices.
• Good organizational skills and attention to detail.
• Ability to manage and prioritize multiple projects simultaneously and to work within timelines.
• Interest in learning and developing scientific writing skills.
• Interest in learning about international pharmaceutical guidelines and regulatory submission processes.
• Practical experience in method validation of analytical or bioanalytical techniques (for example: HPLC, SEC, CEX, icIEF, CE-SDS, ELISA, etc.) is a plus.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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